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The Latest in Regulatory and Reimbursement
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Biocom submitted feedback on the use of new approach methodologies in drug development. FDA Commissioner Martin Makary has resigned and CDER and CBER are under new leadership. The Agency launched a new inspections pilot and finalized a highly anticipated guidance on chemistry, manufacturing, and control (CMC) flexibilities for cell and gene therapy products. CMS has extended the deadline for manufacturers to participate in the GENEROUS model.
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Biocom Comments on FDA Draft Guidance
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New Acting Leadership as FDA Commissioner Resigns
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Kyle Diamantas, Deputy Commissioner for Food, will serve as the Acting FDA Commissioner after Dr. Makary resigned from his role as Commissioner last month. |
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FDA Drug and Biologics Centers Under New Leadership
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FDA Announces New One-Day Inspections Pilot
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The FDA’s new one-day inspectional assessments pilot launched in April and is intended to complement standard FDA inspections across multiple product inspectorates. |
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Guidance on CMC Flexibilities for CGT Products Finalized
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The FDA has finalized its long-awaited guidance on Chemistry, Manufacturing and Controls Flexibilities for Developing Human Cellular and Gene Therapy Products for a Biologics License Application. |
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CMS Extends Deadline for the GENEROUS Model
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Manufacturers have until June 11 to apply to participate in the GENEROUS Model. The model will allow state Medicaid programs to purchase drugs included in the pilot at prices aligned with those paid in other countries. |
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Request for Comments
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The FDA is seeking public comments on the Commissioner’s National Priority Voucher Pilot (CNPV) Program. Biocom welcomes feedback from members on the following aspects of the CNPV program. Click below to submit comments via email. |
- The program’s eligibility criteria and the voucher selection processes
- Sponsor responsibilities and pre-submission requirements
- FDA review procedures and the role of the CNPV Review Council
- Other aspects of the program’s implementation
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Upcoming Regulatory and Reimbursement Events:
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Featured Members
Congratulations to Biocom member, Gilead, on their FDA approval of Hepcludex, the first approved treatment for chronic hepatitis delta virus.
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Biocom Policy & Advocacy
Biocom is the leading advocate for California’s life science sector. Our Policy & Advocacy staff across the Bay Area, Los Angeles, San Diego, Sacramento and Washington, D.C. work with lawmakers and regulators to shape policy and strengthen government relations through coordinated regional, state and federal engagement, supporting industry growth and keeping California globally competitive.
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